OTTAWA – Health Canada is advising Canadians that Auro Pharma Inc. is voluntarily recalling one lot of Auro-Irbesartan/hydrochlorothiazide (HCT) combination tablets because of a nitrosamine impurity, N-nitrosodiethylamine (NDEA). The affected lot was released in August 2018 and distributed only in Ontario and Quebec.

NDEA is classified as a probable human carcinogen, which means that long-term exposure could increase the potential risk of cancer. Auro Pharma Inc. is conducting the recall after Health Canada’s testing identified levels of NDEA above what is considered reasonably safe if the drug were taken over a lifetime.

Irbesartan is an angiotensin receptor blocker (ARB) drug, also known as a sartan. Sartans are a class of drugs used to treat patients with high blood pressure to help prevent heart attacks and stroke. They are also used in patients who have had heart failure or a recent heart attack.

There have been multiple recalls of products containing other sartans in Canada and internationally since July 2018 because of nitrosamine impurities (see links below for more information). Health Canada continues to work with companies and international regulatory partners, including the U.S. Food and Drug Administration and the European Medicines Agency, to assess the issue of nitrosamine impurities in certain sartan drugs, its root causes and mitigation measures.

As with previous recalls involving nitrosamine impurities, Health Canada is advising that there is no immediate risk to patients taking these medications since the potential risk of cancer is with long-term exposure to impurities that exceed safe levels. Patients should not stop taking their medication unless advised to do so by their healthcare provider.

There are alternative products currently available on the Canadian market. Health Canada continues to monitor the supply situation. Health Canada encourages Canadians to visit drugshortagescanada.ca for information on drug shortages and discontinuances. Patients with questions or concerns about any drug they are taking, including on what to do if that drug is not readily available, should speak to their healthcare professional.

Affected products

Auro-Irbesartan HCT tablets

Product description

Auro Pharma Inc. is recalling the following product because of an NDEA impurity. Health Canada maintains a complete list of sartan drugs that have been recalled because of nitrosamine impurities on its website.